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摘要
An efficient and convenient reversed-phase high-performance liquid chromatography method has been developed and validated for the quantitative determination of cholic acid bulk drugs and their related impurities. Chromatographic separation was performed on a YMC-Pack ODS-AQ column (250 mm x 4.6 mm, S-5 mu m, 12 nm), and the mobile phase consisted of acetonitrile, methanol, and diluted formic acid solution (pH 2.5) at a flow rate of 1.0 mL/min. The analytes were monitored using a refractive index detector at 30 degrees C, and the column temperature was 30 degrees C. Under the above chromatographic conditions, the method has good specificity and specified impurities can be effectively separated. The proposed method is found to have linearity in the 2.0-80.0 mu g/mL concentration range with correlation coefficients of not less than 0.9999. The compounds analyzed in the solutions are stable for at least 7 days, and spike recoveries for all specified impurities range from 91.3% to 109.3% with relative standard deviations (RSDs) not more than 7.3%. The limit of detection and the limit of quantification for the analytes are 0.060 mu g/mL and 2.0 mu g/mL, respectively. The proposed method can be applied in the quality control assay of cholic acid bulk drugs, with the advantages of simplicity, accuracy, robustness, good selectivity, and high sensitivity.
- 出版日期2018-6
- 单位五邑大学
